The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cedars-sinai Quantitative Thallium-201 Analysis.
| Device ID | K915644 |
| 510k Number | K915644 |
| Device Name: | CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda, CA 92686 |
| Contact | Van Train |
| Correspondent | Van Train NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda, CA 92686 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-02-27 |